Warnings And Cautions - Welch Allyn Insight 13500 Directions For Use Manual

Warnings and cautions

All users of the Insight BIO must read and understand all safety information presented in
this manual before using the device.
WARNING The Welch Allyn 13500 Insight BIO is classified as a Group 2
instrument according to EN/ISO 15004-2:2007. The classification was
performed together with a Ø54mm/20 Diopter Ophthalmoscopy loupe.
WARNING The light emitted from this instrument is potentially hazardous.
The longer the duration of exposure, the greater the risk of ocular damage.
Exposure to light from this instrument when operated at maximum
intensity will exceed the safety guideline after 10 minutes.
WARNING Because prolonged intense light exposure can damage the
retina, the use of the Insight Binocular Indirect Ophthalmoscope for ocular
examination should not be unnecessarily prolonged, and the brightness
setting should not exceed what is needed to provide clear visualization of
the target structures. This device should be used with filters that eliminate
UV radiation (˂400 nm) and, whenever possible, filters that eliminate UV
short wavelength blue light (˂420 nm).
WARNING The retinal exposure dose for a photochemical hazard is a
product of the radiance and the exposure time. If the value of radiance
were reduced in half, twice the time would be needed to reach the
maximum exposure limit. While no accurate optical radiation hazards have
been identified for indirect ophthalmoscopes, it is recommended that the
intensity of light directed into the patient's eye be limited to the minimum
level which is necessary for diagnosis. Infants and persons with aphakia or
other eye disease/disorders may be at greater risk. The risk may also
increase if the person being examined has had any exposure with the same
instrument or any other ophthalmic instrument using a visible light source
during the previous 24 hours. This will apply particularly if the eye has been
exposed to retinal photography.
CAUTION Charge the Insight BIO only with the provided charger. Using
any other charger could damage the instrument.
CAUTION Do not autoclave, immerse, excessively wet, or use germicidal
cleaners other than those identified. Doing so will damage the instrument.
CAUTION United States Federal law restricts this device to sale,
distribution, or use by or on the order of a physician or licensed healthcare
professional.
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